clinical trial memantine + cholinesterase inhibitor

Introduction

Study design:

• randomized, double-bind, placebo-controlled trial.
• 24 week study conducted at 37 sites in USA between 06/11/01 & 06/03/02
• 404 patients with moderate to severe Alzheimer's disease
• 322 patients (80%) completed study
• mini mental status scores between 5-14
• all patients receiving stable doses of donepezil

Intervention:

• patients randomized to receive memantine or placebo for 24 weeks
• starting dose of memantine 5 mg/day
• dose increased to 20 mg/day

Results:

• change from baseline on Severe Impairment Battery favored memantine group +0.9 vs -2.5 (100 point scale) (p < 0.001)
• change from baseline on ADCS-ADL19* favored memantine group -2.0 vs -3.4 (54 point scale) (p = 0.03)
• change in CIBIC-plus# favored memantine group 4.41 vs 4.46 (scale of 1-7) (p = 0.03)
• treatment discontinuation greater for placebo group (25 vs 15)

* Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory

• modified 19 item version

* Clinician's Interview-Based Impression of Change Plus Caregiver Input

Conclusion:

• outcomes significantly better for memantine than placebo group

Study supported by Forest Laboratories

Also see Memantine clinical trials

More general terms

• clinical trial

Additional terms

• memantine clinical trials